The collapse of SVB’s healthcare investment arm is likely to significantly impact the medical device industry, particularly for startups seeking financing.
Linda Braddon, Ph.D., Founder and CEO, Secure BioMed Evaluations 05.23.23
Historical control refers to the use of data from past studies to estimate potential response to a placebo or standard care treatment among trial patients.
This new divergence between EU and U.K. requirements also means different rules apply to Great Britain (England, Scotland, and Wales) and Northern Ireland.
Planning for a regulatory submission entails consideration of numerous requirements beyond simply the content and required elements of the application.
Bryan Brosseau, Founder and Principal Consultant, Brosseau Consulting LLC 09.14.21
This column focuses on the directive under EU 2017/745 on medical devices (MDR), highlighting some of the changes in claiming and demonstrating equivalence.
Cindy Boyer, Senior Manager, International Regulatory Affairs, MCRA LLC 11.18.20